# K240371: 0909FCC, 0909FCC-HS

- Pathway: 510(k) (Special)
- Applicant: Rayence Co., Ltd.
- Decided: Mar 7, 2024 after 29 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K981556 (1998). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212753: 0909FCB, 1212FCA, Rayence Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K253800: 0909FCE, 0909FCE-HS (2026), 0 descendants of its own

## Indications for use
“0909FCC and 0909FCC-HS are indicated for digital imaging solution designed including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). The detectors are intended to replace the x-ray imager on film based radiographic diagnostic systems. Not to be used for mammography.”

Source page: https://510kreport.com/device/K240371
Methodology: https://510kreport.com/methodology